View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
2070-0038
ICR Reference No:
202206-2070-002
Status:
Historical Active
Previous ICR Reference No:
201607-2070-001
Agency/Subagency:
EPA/OCSPP
Agency Tracking No:
1188.13
Title:
TSCA Section 5 Premanufacture Review of New Chemical Substances and Significant New Use Rules for New and Existing Chemical Substances
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
12/29/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/30/2022
Terms of Clearance:
In accordance with 5 CFR 1320, the information collection is approved for three years.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2025
36 Months From Approved
12/31/2022
Responses
4,286
0
14
Time Burden (Hours)
136,292
0
137
Cost Burden (Dollars)
0
0
0
Abstract:
This information collection request addresses the reporting and recordkeeping requirements associated with both the new chemicals review and regulatory program and the existing chemicals program administered by EPA under section 5 of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Lautenberg Act) (15 U.S.C. 2604). EPA is requesting to renew and consolidate two currently approved Information Collection Requests (ICRs). This consolidated ICR will cover information collection activities associated with Significant New Use Rules (SNURs) for both new and existing chemicals under TSCA, and the premanufacture review program for new chemicals. The consolidated ICR will cover ongoing activities necessary to fulfill statutory mandates in TSCA section 5 for new and existing chemicals.
Authorizing Statute(s):
US Code:
15 USC 2604
Name of Law: Toxic Substances Control Act / Manufacturing and processing notices
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
86 FR 73277
12/27/2021
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 38745
06/29/2022
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
16
IC Title
Form No.
Form Name
Bona Fide Intent Notifications (Bona Fides)
CDX Registration
CDX Registration, electronic signature & Pay.gov setup
Chemical Verification
Customer Notification
Instant Photographic Film Articles
Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX)
Microbial Commercial Activity Notices (MCAN)
Notice of Commencement
Polymer Exemption Post-Manufacture Annual Reports
7710-56
NOC Form
Premanufacture Notice
7710-25
PMN Form
Research and Development Exemption
7710-25
PMN Form
Rule Familiarization
Section 5(e) Orders with Pended Testing/ 5(f) Orders with No Testing
7710-25
PMN Form
Section 5(e) Orders with Triggered Testing
7710-25
PMN Form
Significant New Use Notice (SNUN)
Submitting SNUNs
TSCA Experimental Release Applications (TERA)
Test Marketing Exemptions (TME)
7710-25
PMN Form
Tier 1 Exemptions
Tier II Exemptions
6300-07
BioTech
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
4,286
14
0
-14
4,286
0
Annual Time Burden (Hours)
136,292
137
0
-137
136,292
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
This information collection combines the burdens from two previously approved ICRs, EPA ICR No.1188.12 and EPA ICR No. 0574.18. The total combined burden from these two previously approved ICRs was [192,156 + 137 = 192,293 hours]. The total burden requested for this ICR is [136,292 hours], or a decrease of [56,001hours] from the previous total burden. The difference between the current burden request and the previously approved requests is primarily due to the declining number of section 5 submissions for new chemicals. Additionally, minor adjustments were made in EPA’s estimates of the number of respondents and of the burden. The total combined cost burden from these two currently approved ICRs is $54,542,968 [$26,752+$54,516,216], and the total cost burden requested for this ICR is [$37,354,814]. Once this ICR is approved, it will replace the existing ICRs, resulting in decrease in the estimated total cost burden of $17,188,154 [$54,542,968 - $37,354,814]. The difference between the current cost burden request and the previously approved requests are due to the consolidation of the individual ICRs when calculating the burden, as well as adjustments in EPA’s estimates of the number of respondents and of the burden. In addition to the adjustments listed above, the wage rates and material costs were revised to reflect 2020 dollars for this information collection request.
Annual Cost to Federal Government:
$26,959,416
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Angela Hofmann 202 260-2922 hofmann.angela@epamail.epa.gov
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
06/30/2022
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